Consent in Emergency Research

The Health Research Authority ran a meeting on this in June and I thought I would post a summary for comment

[B]Consent in emergency care research: we have a legal compass and an ethical framework. Emergency research should not be problematic

On the 21st June 2012, the Health Research Authority organised a meeting of researchers and members of research ethics committees (RECs) to consider the ethical dimensions of seeking consent during an emergency. Presentations and discussion confirmed the consensus that research is essential as the only reliable way to improve care but also outlined current difficulties. Patients are dying because of the current dearth of evidence.

It was accepted that patients who need urgent treatment are vulnerable. It’s very likely they will lack capacity to give their consent nor may there be time to consult others. Yet without research they are “doubly vulnerable”. Not only are they unable to represent their own interests but without this research, they may be given treatments which don’t work or could even be harmful.

So what is a fair way forward, how should we seek consent in emergency care research? This is of particular importance now we have evidence that the current emphasis on informed consent can result in meaningless “agreements” and may even seriously harm patients and participants (1)
There is, however, a more realistic view emerging. Law and moral considerations now give us a framework to help us decide when “consent or consultation at the time” could be waived. If this is adopted by both researchers and Research Ethics Committees research, in which public and patients will have trust and which will improve care, can be facilitated, regulated and conducted.

Those at the meeting could agree on several points:-

Ethical research has to replicate, and therefore cannot change, practice. Separate treatment standards and schedules are ethically and scientifically unjustifiable.
There was support for the principles, in tune with the principles of the Mental Capacity Act in England and Wales, that a potential participant’s capacity should be honestly assessed and practicable steps to help them make their own decision need to be taken . It was agreed that decisions on behalf of people who lack capacity must not be against their best interests.
There was support for the conditions for fair emergency trials without “consent or consultation at the time”
1. Treatment is needed urgently and the nature of the trial also requires urgent action
2. It’s impractical to seek consent or consult others
3. There is agreed equipoise or uncertainty about the better treatment
4. A REC has given favourable opinion
5. The Investigator has undertaken to conduct the research in accordance with applicable legislation; guidance and under organisational, regulatory and professional oversight

There was support for a framework of questions for researchers and RECs:-
1. Is there a need for this research?
2. Is there agreed uncertainty about treatment?
3. Does this work need to recruit those who lack capacity? Could the research question be answered by research involving those with capacity?
4. Will the efficacy of an intervention diminish with time; does it need to be given quickly?
5. Would delay undermine the science of the study?
6. In the context of the research is consent feasible?
7. Would consent delay treatment and therefore NOT replicate practice?
8. Will all reasonable steps be taken to promote capacity?
9. Would seeking the opinion of a personal or legal representative / consultee delay treatment?
10. Would the legal representative/consultee themselves have capacity?
11. What is the practicality and validity of consulting a representative unconnected to the research?
12. What should the patient, consultee or legal representative be asked later?

If this framework is to work, those involved need to agree to it, understand and discharge their responsibilities.
Researchers must provide a considered protocol and determine how they will approach consent . If consideration is being given to waivers for consent and enrolment is 'automatic' then the quality of documentation around this must be of sufficient detail to allow full reconstruction of the decision making processes.
The Health Research Authority must be prepared to contribute advice and support and work through its National Research Ethics Service to deliver a robust, consistent approach. For their part, RECs must have the understanding and expertise to provide a fair evaluation (there was support at the meeting for establishing RECs with knowledge and expertise in this area) and understand their role and decisions they can make. Shared training will play a key role and this meeting showed that, although we come from different positions, collaboration is clearly possible. Some issues are unresolved and need further work, but, in our shared goal of promoting ethical research in this area we are pushing against an opening door.

However there were unresolved issues

• The inconsistency of establishing whether someone has or lacks capacity remains
• The true benefit and risks of being in a research study remain the subject of opinion rather than evidence, and hinder fair research design and review.
• The value and even meaning of a legal representative’s opinion and its contribution to research subject protection is contended.
• The scope of “consent after the event” is under continuing debate. To what would they be agreeing ((or disagreeing) and what data should remain in the trial?
• What should happen if the subject died and is that a need to seek legal representative’s consent to use the data?
• The role of community consultation, promoted in the USA and required in some EU member is ill defined and at times problematic.